REGULATORY

FDA Touts Its Record on Approvals

Podcast: December 10, 2012

The Burrill Report


The Burrill Report (December 10, 2012): FDA Touts Its Record on Approvals (.MP3,10.96 Mb)

The U.S. Food and Drug Administration approved 35 new drugs in fiscal 2012, according to a report from the agency that finds all but one of those were approved within their target dates for action. What’s more, about one-third of those drugs were approved under the agency’s Fast Track designation. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, about the new report, challenges the agency faces, and whether the improved performance reflects changes at the FDA, or better quality submissions from the industry.











December 07, 2012
http://www.burrillreport.com/article-fda_touts_its_record_on_approvals.html